Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Abbott shares safety concerns with millions of CGM sensors—7 deaths reported
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.
Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs
The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.
Adjustable interatrial shunt for heart failure shows promise in first-in-human trial
Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.

cybersecurity hacker ransomware cyber data breach

FDA announces recall for Johnson & Johnson devices due to cybersecurity risk—customers urged to act

The FDA and Johnson & Johnson MedTech are telling customers to keep the devices in a secure environment until they can be disabled from all networks.

Manikin medical deoll device from MedVision

AI ‘manikins’ create lifelike simulations for medical students

The robots can be used to simulate medical emergencies, like seizures and heart attacks. They were demonstrated at a college in North Carolina, where clinical students are getting hands-on learning.

California passes law to regulate private equity activity in healthcare

California Gov. Gavin Newsom signed into law SB 351, which improves regulatory oversight of dental and physician clinics owned by investment firms.

Florida patient sues hospital, cardiology practice for alleged negligence after leg amputation

The patient alleges she experienced significant delays in care after being rushed to the hospital for acute limb ischemia. She also says no vascular surgeons were available, limiting her treatment options.

The U.S. Food and Drug Administration (FDA) granted pre-market approval (PMA) clearance for Zoll Zenix defibrillator-monitor for EMS and hospital use. It incorporates new technology and features based on years of user feedback.

FDA approves Zoll's newest defibrillator-monitor

The device, based on years of user feedback, is now cleared for use in both EMS and hospital settings.

New expert guidelines examine the use of temporary MCS during heart surgery

Three leading medical societies collaborated on the new document, providing detailed recommendations that cover a wide variety of technologies and clinical scenarios.

FDA approves subcutaneous diuretic treatment for heart failure-related edema

The newly approved drug-device combination helps patients manage their own treatment from the comfort of home.

Missouri state house capitol Jefferson City

Planned Parenthood sues to block Missouri’s request for abortion records

The Missouri attorney general has demanded details on patient care, communications between providers and pregnant women, maintenance records and more in an effort to identify state residents who have sought abortions.

Clinical

Medtronic recalls data management software, urging healthcare providers to run update

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

Adjustable interatrial shunt for heart failure shows promise in first-in-human trial